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MAS SARS-CoV-2 IgG Positive Control

FDA UDI

Class I (US FDA UDI)

by Microgenics Corporation

Identity

Trade Name
MAS SARS-CoV-2 IgG Positive Control FDA UDI
Generic Name
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control FDA UDI
Model / Reference
10028305 FDA UDI

Identifiers

Primary DI / UDI-DI
00884883007765 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control

MAS SARS-CoV-2 IgG Positive Control by Microgenics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microgenics Corporation

Sources (1)

  • FDA UDI 81de0247-dd6e-4ac1-8cc9-2442eaa1ec98 32 fields · synced Jun 9, 2026